Standing Up to Bogus Scientific Claims Made By Republicans!

As I scientist, I find it offensive that Republican Presidential candidates like Michele Bachmann and Rick Perry are allowed to spew false claims and scientifically-wrong information to the public without a peep from the scientific community. Perhaps many scientists choose to not publicly speak out--even though they know that the information is wrong or unsubstantiated--because they don't want to attract attention to their often arcane research for fear that their funding may be cut.  Or, maybe,scientists too often believe that the public won't understand what they say anyway. Whatever the reason, I applaud two bioethicists, Art Caplan at the University of Pennsylvania and Steve Miles at the University of Minnesota, for standing up to Michele Bachmann, a tea party Republican presidential hopeful, assertions that  human papillomavirus (HPV) vaccines--that protect against cervical cancer --cause mental retardation in those girls who are vaccinated with them.

Caplan accomplished this by publicly offering $10,000 to charity if  Bachmann can prove her claim that she mad during a GOP debate on Monday night that HPV vaccination causes mental retardation. Similarly, Steve Miles offered $1,000 to Bachmann if she could substantiate her claims.

At present, HPV vaccination is voluntary. Further, there is absolutely no clinical data that links HPV vaccination to the onset of autism or for that matter mental retardation. As many of you know by now, the research that was used to show a link between childhood vaccinations and autism was fabricated and the scientist who performed the work was found to be a fraud.

Unfortunately, many politicians feel compelled to share their scientific views-- and make claims to support those views--without being qualified or trained to analyze whether or not the claims they make are scientifically accurate or valid.  Anecdotal, scientifically-unproven rhetoric is unacceptable when making scientific claims for or against a specific product.  To that end, I suspect that if Merck and GSK, the manufacturers of two FDA-approved HPV vaccines, were so inclined they could possibly file defamation lawsuits against Bachmann. This is because I believe that she intentionally made comments that are known not to be true with malicious intent. Interestingly, sales one of the HPV products, Merck's Gardasil, have recently hit an all time low!

I think it is time for the scientific community to publicly debunk many of the scientific myths e.g., vaccination and autism, creative design and that global warning is not real,  perpetrated upon the public by bat-shit crazy members of the tea party, right wing conservative republicans  and religious zealots.  Failure to do so will lead to the ongoing decline in STEM preparedness and competitiveness in the US.

Hat tip to Drs. Caplan and Miles for publicly challenging one of the many scientifically-illiterate candidates running for president.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Competition for Pharma Talent Is Heating Up in Emerging Markets

While R&D scientists and sales representatives continue to struggle to find jobs in the US at pharmaceutical and biotechnology companies, the competition is fierce to hire and retain pharma employees in emerging markets like China and India. Earlier this week, I posted a piece on big pharma’s continuing expansion of its R&D activities in Asia and the growing need for US-trained PhDs in this region. However, it appears that hiring and retaining pharma sales reps is a bigger problem in China and India for big pharma companies like GlaxoSmithKline (GSK), Sanofi-Aventis (SA) and Pfizer.

According to a recent article in Bloomberg News about 20 percent of GSK’s sales forces in both countries quits each year in favor of better offers from its rivals including Pfizer and SA. One GSK executive quipped “There’s a huge war for talent. It’s hard to do anything about. If you have a good person, they could find someone else willing to pay twice as much.” This is in marked contrast with the US where almost 100,000 pharma sales reps may have lost jobs over the past five years.

Emerging Asia Pacific markets accounted for roughly 17 percent of GSK’s sales in 2010 as compared with 18 percent for Pfizer and 30 percent for SA. Sales revenues for most major pharmaceutical companies declined in both the US and Europe last year. There is no question that big pharma is turning to emerging markets as a means to maintain and increase sales of drugs after patents expire and generic competition cuts into revenue. Sales in emerging markets are predicted to reach about $400 billion by 2020 which is equivalent to the current size of the US and the five biggest European markets combined!

By its own admission, GSK was “fairly late” in their investments in China and may explain why the company may be experiencing trouble with competing for talent in that market. Employment opportunities in emerging markets will likely resemble those in the late 1990s in the US and Europe, when there was a dearth of talents life sciences professionals and companies were willing to pay large salaries (regardless of whether or not job candidates were qualified) to employees to maintain operations. This trend is driving up labor costs in China and interestingly, China is beginning to outsource work to Vietnam, Malaysia and Singapore where labor and raw materials costs are less expensive.

Until next time....

Good Luck and Good Job Hunting (Go East Young Man and Woman)

 

Unemployment Update: Almost 300,000 Pharma Jobs Lost Since 2000

Mathew Herper, who writes at the Forbes Blog, reported today that according to a report compiled by the outplacement firm Challenger, Gray and Christmas, since 2000 the pharmaceutical industry cut 297,650 jobs. According to Herper “that is about as many people as currently work at the three largest drug makers — Pfizer, Merck, and GlaxoSmithKline — combined.” As he aptly points out “Many of those who were laid off were probably hired back by other drug makers. Some folks have probably been laid off more than once. It’s also worth noting that big mergers are one reason for the cuts.”

Nevertheless, the number of lost jobs is staggering. Interestingly, while almost 300,000 jobs have been lost in the last decade, a majority of the cuts (234,814) have taken place over the past six years (see below).   It is not clear from the report whether or not these numbers include the numbers of jobs lost by the aggregate life sciences industry (including biotech and specialty pharma) or only by the pharmaceutical sector.    

Year No. Jobs Lost
2000   2,453
2001   4,736
2002 11,488
2003 28,519
2004 15,640
2005* 26,300
2006* 15,638
2007* 31,732
2008* 43,014
2009* 61,109
2010* 53,636
2011 (to date)   3,387
TOTAL 297,650

   Source: Challenger, Gray & Christmas, Inc. © (via the Forbes Blog)

With mergers on the way and more jobs being outsourced to Asia and elsewhere, don’t be surprised if the total number of layoffs continues to grow.

Until next time

Good Luck and Good Job Hunting!!!!!!!!!!

 

Is GSK Really Backing Away from Neuroscience R&D?

Ask any pharmaceutical industry pundits about the “next big thing” in life sciences R&D and most will invariably say neuroscience indications like Alzheimer's, Parkinson Disease and the like. Curiously, despite these prognostications, GlaxoSmithKline (GSK) today announced that it would lay off 50 employees involved in neuroscience R &D.

The affected workers, all of whom are scientists working on late stage clinical development at various sites throughout the US, were first notified about the layoff on Valentine’s Day (nice gift). Interestingly, a GSK spokesperson was quick to point out that other neuroscience employees including marketing and sales would not be affected by the layoffs. Hm mm, I always thought you needed scientists to discover the drugs that will ultimately be marketed and sold by a company? In any event, no GSK operations outside of the US were affected by this round of layoffs.

The reason why the layoffs only affected clinical scientists is because GSK scaled back its investment into early stage research. And, according to the GSK spokesperson this means that “there’s not as much coming through that needs later stage clinical trials.” Also, last year, after GSK released fiscal 2009 results, the company announced it would “cease discovery research in selected neuroscience areas, including depression and pain.” I guess most of the layed off scientists worked on depression and pain (two emotions that layed off workers frequently suffer).

In case you haven’t noticed (because you spend too much time in the lab and on Facebook), most major pharmaceutical and biotechnology companies have slashed their investments into new drug discovery and development. This means that the demand for R&D scientists (in the US anyway) is much lower than ever before. Consequently, as I have stated numerous times in the past, now may be the time for graduate students and postdocs considering industrial R&D careers to re-evaluate their plans (unless R&D careers in emerging markets like Brazil, Russia, India and China are attractive).

Until next time ....

Good Luck and Good Job Hunting

 

Sanofi-Genzyme Update: GlaxoSmithKline Isn't Interested

For those of you who can’t tear yourselves away from the ongoing, nail-biting Sanofi Aventis-Genzyme saga, the head of GlaxoSmithKline (GSK) R&D, Moncef Slaoui told a French newspaper that GSK will not “step in as a rival bidder for the US biotech Genzyme.”

Slaoui made his remarks at the christenings of a GSK research center in France. “An offer by GlaxoSmithKline for Genzyme does not make sense. It is too expensive” he said. Also, GSK already has a foothold in the orphan disease market through its partnership with JCR Pharmaceuticals. 

As negotiations between Sanofi and Genzyme began to stall over the $69 per share offer tendered by Sanofi, some analysts had predicted that a so-called white knight may enter the bidding war to drive the stock share price higher to the $75 per share wanted by Genzyme.

Today’s announcement by GSK likely produced a collective sigh of relief from Sanofi shareholders. Personally, I think Sanofi would be crazy to let this one get away; the deal is exactly what Sanofi needs to begin to compete in the lucrative biologics market. Until now, Sanofi’s focus has been almost exclusively on small molecule development.

Until next time..

Good Luck and Good Job Hunting!!!!!!!!!!

 

Correction: High not "Hit" Throughput Screening

Yesterday, I posted a piece on "hit'  throughput screening (see below).  At the time, I learned about  'hit" throughput screening, I mentioned that  I had never heard of "hit" throughput screening but I did know about high throughput screening.  As it turns out, there was a problem in translation and in fact, there is no such thing as hit throughput screening and it is actually high throughput screening.  Mea Culpa!  I apologize for the error and in the future I will be assiduous in my fact checking before I post (a lesson that the boneheads in the Obama administration learned the hard way in the recent Sherrod brouhaha)

The Growth of High Throughput Screening

No; this isn’t a typo! My colleagues at Meet the Boss sent me a press release today about efforts underway at Pfizer and GlaxoSmithKline to redefine HTS to mean “hit” throughput screening rather than high throughput screening. As many of you may know, high throughput screening which began in the mid 1990s was supposed to revolutionize drug discovery and development—it did not! Nevertheless, after almost 15 years of refinement it appears that the technology may be paying off and can be used as an adjunctive tool to expedite and lower the cost of small molecule and protein-based drug discovery. While I don’t know much about this emerging technology, the press release presented below suggests that a meeting about HTS may be in the works. 

It is understood that huge amounts of money have been invested into drug discovery and the biggest problem faced by the industry is investing in drugs which may not make it onto the market. Europe has always been seen to trail behind the US when discussing drug discovery within the pharmaceutical industry, but with the biotechnology revolution they have begun to catch and becoming a driving force within the global industry.

The NGP EU committee has been celebrating the success of their pioneering roles in genome sequencing and the development of proteomic. Pfizer has recently announced to the NGP Drug Discovery committee that they plan to roll out a hit identification and screening file strategy. The process will offer a new flexible strategy for hit identification while sculpting a more reliable and efficient screening process. 

High throughput screening (HTS) has grown rapidly over the last ten years and Pfizer themselves noted the huge advances in both detection technology and laboratory automation. Pfizer believe that not only big Pharma but also smaller companies can implement HTS as well. By implementing HTS,  it can remove the indecision over which compunds will be profiles, many smaller companies agonize over the costs of conventional profiling sometimes only choosing between 10 and 20 compounds, this already removes other possibilities before true research can really begin. Pfizer among other members of the NGP EU Drug Discovery committee wish to discuss how they wish to implement large scale profiling at a lower cost, while maintaining the incredible biological, technological, and scientific advancements they are already demonstrating globally.

GSK have also joined Pfizer recently in encouraging the implementation of HTS. “We are now at a stage where we can exploit the benefits of cutting edge technology for increased quality, performance and capabilities. We also have the option to supply the same number of compounds, with the same level of quality at an affordable price”. 

Key to discussions will be representatives from AstraZeneca - Goran Wennberg, VP Discovery Information, Bayer Schering Pharma - Andreas Busch, Head of Global Drug Discovery & Member of the Board , Novartis - Olivier Grenet , Group Head of Genome Biology ,GlaxoSmithKline - Tino Rossi, VP of PreClinical Drug Discovery & Enabling Technologies and Pfizer - John Mathias, Head of High Through Put Screening all determined to firmly place Europe as the Drug Discovery capital.

The discovery and implementation of HTS not only offers an opportunity to smaller Pharma companies but also the consumer, if research and quality is increased and cost decreased this in turn will be passed onto the consumer.

Stay tuned for more details.

Until next time...

Good Luck and Good Job Hunting

 

Pharma Edges Closer to Using Social Media for Non-Promotional Purposes

Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.

According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.

While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development. 

CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online's proprietary databases of oncology information. Other apps for RIM's BlackBerry and Google's Android operating systems will be released over the next several months.

Hat tip to GSK which has boldly gone where no other pharma company has gone before!

Until next time....

Good Luck and Good Job Hunting!!!!!

 

Big Pharma is Betting on Emerging Markets to Lift Profits

It is no secret that growth of the pharmaceutical industry has slowed to single digits in the past five years or more. In fact, many experts don’t expect there to be double digit growth in this sector for a long time. Instead, future robust growth of the pharmaceutical industry is expected to take place in emerging markets including India, China, Brazil, South Africa and others. This is because the economies of these countries are booming and the middle class in these nations continues to rapidly grow. 

While branded prescriptions drugs once dominated Western markets, it is likely that generics or branded generic products will be the major players in emerging markets. Because of this, big pharma companies such as GlaxoSmithKline, Daiichi Sankyo and most recently Abbott Laboratories have either purchased or crafted large marketing deals with smaller regional drug manufacturers.

Daiichi Sankyo paid $4.0 billion in 2008 for a major share of India’s Ranbaxy Laboratories and GlaxoSmithKline earlier this year acquired exclusive rights to over 100 products produced by Dr. Reddy’s Laboratories, another Indian drug maker with a broad reach in emerging markets.

Today, Abbott Laboratories announced that it would purchase the healthcare business of Piramal Healthcare Ltd, one of India’s largest purveyors of branded generics for $3.72 billion. When the deal closes, Abbott will inherit the rights to about 350 brands and trademarks and a manufacturing plant in northern India. Also, Piramal agreed to a six year non-compete agreement for branded generics. The remaining parts of Piramal include a custom manufacturing business, over-the-counter products, vitamins, diagnostic devices and Piramal Life Sciences a drug discovery company.

The company, which has India’s largest sales force, would become a subsidiary of Abbott Laboratories and employ about 7,500 workers. Last week, Abbott said it would license at least 24 products from Zydus Cadila to sell in emerging markets. Analysts estimate that emerging markets account for 20 percent of Abbott’s business. The Piramal and Zydus Cadila deals suggest that Abbott maybe the company to reckon with in emerging markets in India and elsewhere.

 Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

FDA Asks GlaxoSmithKline to Suspend Sale of Its Rotavirus Vaccine

The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to suspend sale of Rotarix, its rotavirus vaccine, because it may contain porcine circovirus type 1 (PCV-1) DNA sequences. The FDA and the company both found traces of PCV-1 DNA in the vaccine. It is not clear whether whole virus is in the vaccine or just pieces of its DNA. Luckily, PCV-1 isn’t known to cause disease in humans and infants vaccinated with the vaccine are not likely to experience any health or medical issues..

The agency insists that this is a temporary and cautionary suspension of Rotarix sales. FDA officials are advising physicians to use Merck’s RotaTeq rotavirus vaccine instead, which is made using a different method and which shows no evidence of PCV-1 contamination. Merck and GSK have been vigorously competing for market share in the US vaccine marketplace.

Unfortunately, things haven’t been going well for the highly regarded GSK vaccines division in the past few years. First, the company had trouble getting its anti-cervical cancer vaccine, Cervarix approved in the US. And the company just recently announced that it may not seek regulatory approval for Synflorix, a new pneumococcal disease vaccine that was suppose to compete with Pfizer’s  (formerly Wyeth’s) second generation 13-valent pneumococcal vaccine called Prevnar.

This isn’t the first time that animal DNA sequences have been found in human biotechnology products. Last June, Genzyme was forced to shut down one of its biomanufacturing facilities to clean up viral contamination that had been slowing down production of two of its main products, Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme.

Because many vaccine and biotechnology products are manufactured in mammalian tissue culture cell lines, detection of non-human viruses these products are neither uncommon nor unprecedented. However, the recent spate of high profile, virally-contaminated vaccines and biologics suggests that biomanufacturers must be more vigilant when it comes to virus removal and microbiological testing from these products.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

GlaxoSmithKline to Increase the Size of its Sales and Marketing Team in India

According to an article that appeared in the Indian publication The Hindu Business Line, GlaxoSmithKline (GSK) is set to increase the size of its Indian marketing and sales force to better support the sale of vaccines and other specialty products. A company executive said that GSK will add another 200 people to its 2,250 member sales and marketing team.

GSK is repositioning itself to be more competitive in developing and emerging markets like India, China, Brazil and elsewhere. The announcement to increase the size of its workforce in India comes only a couple of weeks after the company announced massive global layoffs that would affect at least 4,000 GSK employees.

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

Layoff Alert: GlaxoSmithKline Reveals Jobs Will Be Eliminated at UK Facility

After announcing that it would lay off about 4,000 workers two weeks and then refusing to disclose which facilities would be affected,  the British drug maker, GlaxoSmithKline (GSK) today revealed that several hundred workers at it Harlow, Essex  facility will lose their jobs. 

The Harlow facility, formerly the headquarters of SmithKlineBeecham which was taken over by Glaxo almost 10 years ago, is located 25 miles (40 km) northeast of London. Although not confirmed, as many as 380 of the 1,1150 employees at the facility may lose their jobs.

Stay tuned for more GSK layoff updates!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!

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Glaxo Continues to Remain Tight-lipped About Looming Job Cuts

Many people, most notably GlaxoSmithKline employees, assumed that GSK management would disclose at its earning call yesterday how many people would lose their jobs in the company’s next round of job cuts announced earlier this week. Surprisingly, management decided not to announce the breadth and depth of layoffs ostensibly increasing the drama and anxiety of its employees about the cuts.

Management’s decision not to disclose the number of employees who would lose their jobs after publicly announced that it would cut up to 4,000 jobs means one of two things according to Jim Edwards of the BNET blog.

“Either that GSK itself has not finished calculating it; or that management believes there’s some sort of PR advantage to not actually saying out loud what everyone already knows.”  

Based on public statements made by GSK spokespeople, Edwards has identified several vulnerable areas where jobs are likely to be cut. These include R&D across the board and one therapeutic area, neuroscience. According to bloggers and insiders who leaked information to the public, the asthma drug Advair may be at risk, as well as metabolic disease product development and sales representatives. Also, there will be reporting structure changes and less emphasis will be place on new product launches in the US. The recent decision to not seek US regulatory approval for GSK’s new, pneumococcal vaccine Synflorix, despite garnering EU approval tends to substantiate this idea.

Elimination of neuroscience as a therapeutic area of interest for GSK was clearly enunciated when the company mentioned during the earnings call

 “Today, we have announced proposals to cease discovery research in selected neuroscience areas, including depression and pain.”

Today, GSK announced that it would close a research center in Verona Italy that specializes in neuroscience research. Approximately 500 workers will lose their jobs after the facility is closed. Unions representing the Italian workers also disclosed in an e-mail message that six facilities worldwide besides Verona will also be closed by GSK.

Less obvious, but clearly written between the lines was the statement made about R&D.

"We have ‘externalised’ approximately 30% of GSK’s discovery research. We are already conducting discovery research with 47 external partners. Our goal is to further increase the level of externally sourced compounds in our pipeline …"

"… We are also looking to reduce R&D infrastructure costs."

Perhaps what may be most troubling to GSK employees who ultimately lose their jobs is the $900 million or more spent on legal fees over the past year. GSK didn’t disclose why the company had incurred such enormous legal bills.

The recent spate of layouts doesn’t mean that any big pharma companies are in financial trouble. As previously mentioned, most of the layoffs are based on future economic predictions and projections which may or may not be realized. Companies are cutting staff and implementing cost savings measures simply to bolster their stock prices and give investors their expected ROI. The economic downturn has provided pharma companies with excellent cover to downsize at will without anybody asking any tough questions. While I feel the pain of workers who have either lost or soon will lose their jobs, the downsizing taking place over the past three years has been a long time in the making. I suspect that many well paid veteran employees turned a blind eye to the internal changes and cues that may have signaled their ultimate demise. 

While downsizing will likely have its anticipated short term effects i.e. bolster flagging stock share prices, it will ultimately hurt the future economic prospects of most big pharma companies. This is because pharma companies will lose many of the talented and experienced workers whose previous hard work and sacrifices contributed to their past successes.  When are the overpaid pharma executives going to realize that it is the rank and file, not them that bring creativity, innovation and ultimately financial rewards to their stakeholders?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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Job Cut Update: GlaxoSmithKline Mum on Number of US Jobs that will be Lost

Despite the announcement late last week in the London Sunday Times that GlaxoSmithKline (GSK) will eliminate 4000 jobs worldwide, company official are refusing to disclose the number of worker who will lose their jobs in the US. Cuts are expected throughout the US including GSK’s R&D facilities in the Philadelphia, PA area and at its US headquarters in Research Triangle Park, NC which employs roughly 5,000 people.

GSK officials typically refuse to share detailed information on how layoffs affect its Triangle work force. Nearly a year ago, the company cut an undisclosed number of workers at a customer response center in RTP. GSK announced a first cost-cutting initiative in October 2007, eliminating thousands of jobs worldwide, and then it expanded that effort in February 2009 with many hundreds losing jobs at it North Carolina facilities in RTP and nearby Zebulon.

This coming Thursday is expected to be pink slip day at GSK.

Until next time....

Good Luck and Good Job Hunting (forget RTP)!!!!!!!

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At Long Last: FDA Approves GSK's Cervarix

Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Late Breaking News: FDA Advisory Panel Recommends Approval of GSK's Cervical Cancer Vaccine, Cervarix®

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

Big Pharma Continues to Embrace Social Media

The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

Good Luck and Good Video Watching!!!!!!! 

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Pharma Beginning to Warm to Social Media

About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

 

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GlaxoSmithKline to Restructure US Pharma Operations

The Pharmalot blog reported yesterday that GlaxoSmithKline (GSK) will tell its US pharma employees today about a new reorganization plan that will include more job cuts. The restructuring will primarily affect sales reps and some R&D personnel. GSK, like most other pharma companies, has been steadily downsizing operations and headcount for the past year or so at its US locations in Research Triangle Park, NC and Philadelphia PA

Look for the layoffs to occur before Thanksgiving—just about the time when employee’s annual bonuses are calculated.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

P.S.  It was learned today by the Phamalot Blog that 1,880 sales reps and sales support staff job will be eliminated over the next few months. Also, the company may consolidate its Philadelphia and Research Triangle Park headquarters.

 

Twenty-Five Percent of American Teenage Girls Were Vaccinated with Gardasil in 2007

The Centers for Disease Control and Prevention said about 25% of teenage girls received at least one dose of Merck & Co.'s Gardasil vaccine in 2007, providing the first national estimate of usage of the company’s controversial anti- HPV (cervical cancer) vaccine.

A 25% usage rate for a a new vaccine during its first year on the market is outstanding. That said, Merck’s Gardasil is the only approved anti-HPV vaccine in the US. Approval of GlaxoSmithKline’s competing product, Cervarix, by FDA has been delayed for so-called “regulatory issues.” Also, Merck has been heavily promoting Gardasil use via well-crafted DTC ads and a variety of clever promotional campaigns aimed at adolescent girls and their mothers.

Despite all the negative press and Merck’s questionable marketing practices, Gardasil appears to be doing very well—something that Merck desperately needs.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

What Will Merck Think of Next?

The recent bad press about Gardasil, Merck’s anti-cervical cancer vaccine, must have been keeping its marketing and advertising executives up at night because the company recently launched a marketing campaign called Charm4Life—a line of jewelry designed to raise awareness about cervical cancer. According to a post at the Pharmalot Blog, women (or concerned men) can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani.  The Charm4Life campaign could also be in response to the likely approval early next year of Cervarix, GlaxoSmithKline’s anti-HPV vaccine.

Merck insists that the campaign is to promote awareness about cervical cancer and that all proceeds from sale of the bangles will go to the Prevent Cancer Foundation. Of course, the real goal of the campaign is to promote Gardasil vaccination by raising their awareness of cervical cancer.  

The $32 price tag for the bangles is way cheaper than the $365 it costs for the Gardasil vaccination series. That said, I hope women don’t buy the bangles and forego Gardasil vaccination.

 

Hat tip to Ed at Pharmalot

 

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!

GlaxoSmithKline is the Next Big Pharma Company to Embrace Social Media

It was only a matter of time after J & J launched its health channel on YouTube two weeks ago, that other pharma companies would begin to post videos on video-sharing sites. As a general rule, nobody in pharma wants to be first but after the first company takes the plunge, nobody wants to be left out or behind. Therefore, it came as no surprise when late last week, GlaxoSmithKline (which has a tendency to be second-to-market with competing products), launched a beta version of it so-called GSKCIC channel on You\Tube.

 According to a post on the Pharmalot blog, so far there are only two videos on the channel. One describes the company ongoing commitment and fight against disease in the developing world (ironically, the video ends prematurely).The second, which is full length, features CEO Andrew Witty telling us about his career at GSK (which began in 1985 as a management trainee) and how GSK is looking for a few good employees who “like a good challenge.” Curiously, the day after the Witty video appeared on YouTube, GSK announced that it was laying off about 90 workers or 10% of its work force at its manufacturing plant in Zebulon, North Carolina. A company spokesperson said that more cuts are expected at the North Carolina facility.

Maybe someone at GSK ought to tell its CEO that the company isn’t hiring at the moment?????????

Hat tip to Ed at Pharmalot!

Until next time….

Good Luck and Good Job Hunting!!!!

Is There Another Storm Brewing at Merck?

The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!